# FDA 483 - Institute of Applied Medicine, Inc - September 05, 2014

Source: https://www.globalkeysolutions.net/records/483/institute-of-applied-medicine-inc/84a1fedb-cf06-47b1-b129-ce5ca8a6c6ca

> FDA 483 for Institute of Applied Medicine, Inc on September 05, 2014. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Institute of Applied Medicine, Inc
- Inspection Date: 2014-09-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Institute of Applied Medicine, Inc. in Ishikari, Japan, a contract testing laboratory, revealed three significant observations. The firm failed to establish adequate written procedures for equipment cleaning based on validation, did not calibrate instruments at suitable intervals, and maintained incomplete laboratory records for microbial limit tests. These issues indicate deficiencies in quality control and data integrity practices.

## Related Officers

- [Ademola O. Daramola](https://www.globalkeysolutions.net/people/ademola-o-daramola/814113a4-38bc-4ce5-b6af-09c7e688c0ec)

Company: https://www.globalkeysolutions.net/companies/institute-of-applied-medicine-inc/794cbe58-4248-47b4-84fe-97608c990fe6

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd